GB/T 41726-2022 in English

GB/T41726-2022 systematically standardizes the identification system of 25 ginseng monomer saponins for the first time, covering the technical requirements of key testing equipment such as high performance liquid chromatography and nuclear magnetic resonance spectrometer. The standard innovatively establishes a multi-dimensional identification framework:

• Physical and chemical properties: 9 indicators such as melting point and optical rotation
• Structure confirmation: 13C-NMR and 1H-NMR characteristic peak database
• Purity control: HPLC area normalization method ≥98%

Compared with the 2015 edition of the Pharmacopoeia, the main breakthroughs of this standard are:

1. Added detection methods for 5 rare saponins including Pseudo-ginsenoside F11
2. Established chromatographic separation conditions for 20(S)/20(R) configuration isomers
3. Specified deuterated pyridine as the unified solvent for nuclear magnetic resonance

Typical case: In the detection of ginsenoside Rg3, the use of acetonitrile-water (45:55) mobile phase can achieve baseline separation of 20(S) and 20(R) configurations.

Laboratory configuration requirements

• Temperature and humidity control: 23±5℃, RH25-75%
• Equipment calibration: HPLC pump pressure accuracy ≤0.1MPa
• Standard substances: require joint verification by 3 institutions

Operation precautions

• Pre-saturated chromatographic columns are required for the detection of ginsenoside Rb series
• NMR test samples require strict deoxygenation
• Mass spectrometer ion source temperature is controlled at 300±5℃